The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Stellar M22 For Intense Pulsed Light (ipl) And Laser System.
| Device ID | K193500 |
| 510k Number | K193500 |
| Device Name: | Stellar M22 For Intense Pulsed Light (IPL) And Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Lumenis Ltd. 6 Hakidma Street PO Box 240 Yokneam, IL 2069204 |
| Contact | Shlomit Segman |
| Correspondent | Jonathan Kahan Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | GEX |
| Subsequent Product Code | ONF |
| Subsequent Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-17 |
| Decision Date | 2020-01-16 |